Exufiber Ag+

K160379 · Molnlycke Health Care Us, LLC · FRO · Aug 25, 2016 · SU

Device Facts

• Record ID: K160379
• Device Name: Exufiber Ag+
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: FRO · SU
• Decision Date: Aug 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For over-the-counter use, Exufiber Ag+ may be used for: Abrasions Lacerations Minor cuts Minor scalds and burns Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds: Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers Pressure ulcers (partial and full thickness) Partial thickness burns Donor sites and other wounds that are prone to bleeding, such as debrided wounds Traumatic wounds Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection. Indicated wear time: up to seven (7) days.

Device Story

Exufiber Ag+ is a highly absorbent, gel-forming nonwoven wound dressing; composed of polyvinyl alcohol (PVA) fibers coated with silver sulfate. Applied to medium-to-high exuding wounds; dressing absorbs exudate to form a soft gel, maintaining a moist healing environment. Silver sulfate acts as a preservative to inhibit microbial growth and serves as a barrier to bacterial penetration. Used in clinical settings or home care (OTC for minor wounds); applied by healthcare professionals or patients. Output is a physical barrier and antimicrobial environment; aids in wound management and infection risk reduction. Wear time up to seven days.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing including cytotoxicity, irritation, sensitization, wound healing models, antimicrobial efficacy against 11 strains, silver release kinetics, and minimum effective concentration.

Technological Characteristics

Nonwoven pad or ribbon dressing; material: polyvinyl alcohol (PVA) fibers; antimicrobial agent: silver sulfate (0.2 mg/cm²); sterile (EtO); single-use; highly absorbent, cohesive, gel-forming properties.

Indications for Use

Indicated for abrasions, lacerations, minor cuts, minor scalds/burns (OTC); medium to high exuding wounds including leg/diabetic foot/pressure ulcers, partial thickness burns, donor sites, traumatic wounds, surgical wounds (primary/secondary intention), and oncology wounds with exudate (professional use).

Predicate Devices

• Aquacel Aq Extra Hydrofiber Dressing with Silver and Strengthening Fiber (K121275)

Reference Devices

• Mepilex Transfer Ag (K123892)
• Mepitel Ag (K130040)
• Iodofoam Iodophor Foam Dressing (K122634)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2016

Mölnlycke Health Care US, LLC Ms. Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092

Re: K160379

Trade/Device Name: Exufiber Ag+ Antimicrobial Gelling Fibre Dressing Regulatory Class: Unclassified Dated: July 22, 2016 Received: July 25, 2016

Dear Ms. Bevill:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K160379

Device Name

Exufiber® Ag+ Antimicrobial Gelling Fibre Dressing

Indications for Use (Describe)

For over-the-counter use, Exufiber Ag+ may be used for:

- · Abrasions
- · Lacerations
- Minor cuts
- · Minor scalds and burns

Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:

- · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers
- · Pressure ulcers (partial and full thickness)
- Partial thickness burns
- · Donor sites and other wounds that are prone to bleeding, such as debrided wounds
- Traumatic wounds

· Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions

· Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma

Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.

Indicated wear time: up to seven (7) days.

Type of Use (Select one or both, as applicable)

| <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="text-decoration: overline;">X</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|

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#### 510(k) SUMMARY

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

| Date Prepared: | August 23, 2016 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | MöInlycke Health Care US, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration number: 3004763499<br>Owner/Operator Number: 8030877 |
| Official Correspondent: | Megan Bevill<br>Manager, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Trade/Proprietary Names: | Exufiber Ag+ Antimicrobial Gelling Fibre Dressing |
| Requlation Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device Name(s): | Aquacel Aq Extra Hydrofiber Dressing with Silver and<br>Strengthening Fiber (K121275) |

#### Description of Device:

Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.

#### Intended Use/Indication for Use:

For over-the-counter use, Exufiber Ag+ may be used for:

- Abrasions
- Lacerations ●
- Minor cuts
- Minor scalds and burns

Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:

- Leg ulcers (venous stasis ulcers, arterial ulcers and ulcers of mixed etiology) and diabetic foot ulcers
- Pressure ulcers (partial and full thickness)
- Partial thickness burns
- Donor sites and other wounds that are prone to bleeding, such as debrided wounds ●
- . Traumatic wounds

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- Surgical wounds that heal by primary intention, such as dermatological and surgical incisions . (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
- . Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma

Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.

Indicated wear time: up to seven (7) days.

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## Technological Characteristics:

| Feature | Exufiber Ag+ | Aquacel Ag Extra | Substantial Equivalence Comments |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>clearance | Subject of submission | K121275 | NA |
| Rationale for<br>inclusion | Subject of submission | Predicate device | NA |
| Manufacturer | Mölnlycke Health Care | ConvaTec Inc. | NA |
| Class name | Dressing, wound, drug | Dressing, wound, drug | Same classification as predicate |
| Class | Unclassified | Unclassified | Same classification as predicate |
| Product code | FRO | FRO | Same product code as predicate |
| Indication for<br>use/Intended<br>use | For over-the-counter use, Exufiber Ag+ may be used for:<br>AbrasionsLacerationsMinor cutsMinor scalds and burns<br>Under the supervision of a healthcare professional,<br>Exufiber Ag+ is intended to be used on the following<br>medium to high exuding wounds:<br>Leg ulcers (venous stasis ulcers, arterial ulcers<br>and ulcers of mixed etiology) and diabetic foot<br>ulcersPressure ulcers (partial and full thickness)Partial thickness burnsDonor sites and other wounds that are prone to<br>bleeding, such as debrided woundsTraumatic woundsSurgical wounds that heal by primary intention,<br>such as dermatological and surgical incisions<br>(e.g. orthopaedic and vascular), and surgical<br>wounds left to heal by secondary intention, such<br>as dehisced surgical incisionsOncology wounds with exudate, such as<br>fungoides-cutaneous tumours, fungating<br>carcinoma, cutaneous metastasis, Kaposi's<br>sarcoma and angiosarcoma<br>Exufiber Ag+ may be used for management of wounds as<br>an effective barrier to bacterial penetration of the dressing,<br>as this may help to reduce the risk of infection.<br>Indicated wear time: up to seven (7) days. | For over-the-counter use, Aquacel Ag Extra may be used<br>for:<br>AbrasionsLacerationsMinor cutsMinor scalds and burns<br>Under the supervision of a healthcare professional,<br>Aquacel Ag Extra may be used for the management of:<br>Wounds as an effective barrier to bacterial<br>penetration of the dressing as this may help<br>reduce infectionPartial thickness (2nd degree) burnsDiabetic foot ulcers, leg ulcers, (venous stasis<br>ulcers, arterial ulcers and leg ulcers of mixed<br>etiology) and pressure ulcers/sores (partial and<br>full thickness)Surgical wounds left to heal by secondary<br>intention such as dehisced surgical incisionsSurgical wounds that heal by primary intent such<br>as dermatological and surgical incisions (e.g.,<br>orthopedic and vascular)Traumatic woundsWounds that are prone to bleeding, such as<br>wounds that have been mechanically or<br>surgically debrided and donor sitesOncology wounds with exudate, such as<br>fungoides-cutaneous tumors, fungating<br>carcinoma, cutaneous metastasis, Kaposi's<br>sarcoma, and angioarcomaPainful woundsInfected wounds | The subject device is indicated for the<br>same wound types as the predicate |
| Physical<br>design | Nonwoven pad or ribbon | Nonwoven pad or ribbon | Same as predicate |
| Dressing<br>properties | Highly absorbent, cohesive, gel forming | Highly absorbent, cohesive, gel forming | Same as predicate |
| Dressing<br>material | Polyvinyl alcohol (PVA) fibres | Carboxymethylcellulose (CMC) fibres | The subject and predicate devices are<br>both manufactured from highly<br>absorbent base materials. Exufiber<br>Ag+ has been shown to be suitable for<br>its intended use through<br>biocompatibility and bench testing.<br><br>PVA has been cleared for use in<br>wound care applications under<br>K122634 (Iodofoam Iodophor Foam<br>Dressing), and others. |
| Antimicrobial<br>agent and<br>content | Silver, in the form of silver sulfate<br>0.2 mg/cm², as silver | Ionic silver<br>0.18 mg/cm² | The subject and predicate devices<br>utilize similar antimicrobial agents but<br>in different chemical forms.<br><br>The silver sulfate used in the subject<br>device is the same silver sulfate that is<br>used in other Mölnycke silver<br>dressings, including Mepilex Transfer<br>Ag (K123892) and Mepitel Ag<br>(K130040). |
| Single use or<br>Reusable | Single Use | Single Use | Same as predicate |
| Sterility | Sterile (EtO) | Sterile (gamma) | The subject and predicate devices are<br>both provided sterile and are sterilized<br>by traditional methods.<br><br>Mölnlycke's Mepilex Transfer Ag<br>(K123892) and Mepitel Ag (K130040)<br>dressings are sterilized using the same<br>EtO process as the subject device. |

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#### Performance Data:

In vitro and in vivo methods have been used to demonstrate the safety and effectiveness of the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing with regards to the following parameters:

- Cytotoxicity
- . Irritation
- . Sensitization
- Wound healing model
- . Antimicrobial efficacy against 11 strains
- Silver release kinetics ●
- . Minimum effective concentration

#### Clinical Data:

No clinical data was required to support substantial equivalence.

#### Conclusion:

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics as well as performance testing. Exufiber Ag+ is at least as safe and effective, and performs at least as well as the predicate device, Aquacel Ag Extra.